As Predicted, Merck Has Filed Its sBLA With FDA — For Breakthrough NSCLC PD-L1 Indication, On Keytruda®

On the heels of the disclosure of its strong NSCLC data — in patients whose tumors predominantly express PD-L1, at AACR in Philadelphia this morning (and in the prestigious New England Journal of Medicine) — Kenilworth just said it had recently filed a supplemental biologics license application with FDA, for those sorts of patients, with that variant of lung cancer.

This is exactly as I suggested Merck would, the day after St. Patrick’s, this year. And yes, this is good news. Here’s a bit:

. . . .”In this study, NSCLC patients whose tumors express PD-L1 in the majority of their cells experienced the highest response rates to KEYTRUDA treatment,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to KEYTRUDA in this tumor type. . . .”

Merck recently announced that the company submitted a supplemental Biologics License Application (sBLA) for KEYTRUDA in advanced NSCLC with the U.S. Food and Drug Administration (FDA). Under PDUFA, the FDA has 60 days from submission of the sBLA to determine if the application will be accepted for review. KEYTRUDA was granted Breakthrough Therapy designation in advanced NSCLC by the U.S Food and Drug Administration (FDA) in October 2014. . . .

In addition, Merck expects to file by June 30 with FDA to list Keytruda® as a first line melanoma therapy. [Merck does hold third line FDA approval already, in melanoma, for Keytruda.] All good — and still, BMS holds a clear timing lead here. And so. . . Onward! Do have a blast, one and all.

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